Cleared Traditional

HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY

K051103 · Haag-Streit USA, Inc. · Ophthalmic

Jun 2005

Decision

39d

Days

Class 2

Risk

About This 510(k) Submission

K051103 is an FDA 510(k) clearance for the HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Haag-Streit USA, Inc. (Rockville, US). The FDA issued a Cleared decision on June 7, 2005, 39 days after receiving the submission on April 29, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number	K051103 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 2005
Decision Date	June 07, 2005
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF